Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans - CREOLE

Jun 20, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
GlaxoSmithKline Africa Noncommunicable Disease Open Lab
Date Presented:
03/18/2019
Date Published:
03/18/2019
Date Updated:
06/20/2019
Original Posted Date:
03/18/2019
References

Contribution To Literature:

The CREOLE trial showed that amlodipine plus either HCTZ or perindopril is superior to perindopril plus HCTZ in reducing BP among Black patients from sub-Saharan Africa with HTN.

Description:

The goal of the trial was to compare the safety and efficacy of three different antihypertensive combination medications among sub-Saharan patients.


Study Design

Patients were randomized in a 1:1:1 fashion to either amlodipine plus hydrochlorothiazide (HCTZ) (n = 216) or amlodipine plus perindopril (n = 205), or perindopril plus HCTZ (n = 200). Patients were started at a dose of amlodipine/HCTZ 5/12.5 mg, amlodipine/perindopril 5/4 mg, or perindopril/HCTZ 4/12.5 mg. These doses were doubled after 2 months for another 4 months.

  • Total number of enrollees: 728
  • Treatment group total: 621
  • Duration of follow-up: 6 months
  • Mean patient age: 51 years
  • Percentage female: 63%
  • Percentage with diabetes: 4%

Inclusion criteria:

  • Black race
  • Diagnosed hypertension (HTN) with systolic blood pressure (SBP) 150-179 mm Hg on no therapy, or 140-159 mm Hg on single agent
  • Age 30-79 years

Exclusion criteria:

  • History of cardiovascular disease
  • Secondary HTN
  • Pregnant

Other salient features/characteristics:

  • Office BP: 158/98 mm Hg
  • Ambulatory BP: 146/90 mm Hg

Principal Findings:

The primary outcome, change in 24-hour SBP for amlodipine-HCTZ vs. perindopril-HCTZ, was -3.14 mm Hg, p = 0.03; for amlodipine-perindopril vs. perindopril-HCTZ, was -3.0 mm Hg, p = 0.04; for amlodipine-HCTZ vs. amlodipine-perindopril, was -0.14 mm Hg, p = 0.92.

Secondary outcomes:

  • Change in 24-hour diastolic BP for amlodipine-HCTZ vs. perindopril-HCTZ: -1.05 mm Hg, p > 0.05; for amlodipine-perindopril vs. perindopril-HCTZ: -0.64 mm Hg, p > 0.05; for amlodipine-HCTZ vs. amlodipine-perindopril: -0.41 mm Hg, p > 0.05
  • Office SBP at 6 months for amlodipine-HCTZ vs. perindopril-HCTZ: -4.86 mm Hg, p < 0.05; for amlodipine-perindopril vs. perindopril-HCTZ: -3.6 mm Hg, p < 0.05; for amlodipine-HCTZ vs. amlodipine-perindopril: -1.27 mm Hg, p > 0.05
  • Hypokalemia for amlodipine-HCTZ vs. amlodipine-perindopril vs. perindopril-HCTZ: 5.3% vs. 0.4% vs. 1.7% 

Interpretation:

The results of this trial indicate that the combination of amlodipine with either HCTZ or perindopril is superior to perindopril plus HCTZ in reducing BP among black patients from sub-Saharan Africa with HTN. These are important data and will help inform drug choice for HTN among black patients. The effect on cardiovascular outcomes with different drug strategies would be useful to study in future trials.  

 

References:

Ojji DB, Mayosi B, Francis V, et al., on behalf of the CREOLE Study Investigators. Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans. N Engl J Med 2019;380:2429-39.

Presented by Dr. Dike Ojji at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 18, 2019.

Keywords: ACC19, ACC Annual Scientific Session, African Continental Ancestry Group, Africa South of the Sahara, Amlodipine, Antihypertensive Agents, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Drug Therapy, Combination, Hydrochlorothiazide, Hypertension, Hyperkalemia, Metabolic Syndrome, Perindopril, Primary Prevention


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